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Executive Summary

DDI EXPANDED ACCESS PROGRAM MAY BE AFFECTING ENROLLMENT in controlled clinical studies of the AIDs drug, Bristol Myers-Squibb's Stephen Carter said at a June 23 session of the Sixth International Conference on AIDS. Carter, who heads the clinical research program for ddI, reported that as of June over 9,000 patients have received the drug under the company's expanded access program and approximately 1,000 have enrolled in clinical trials. The expanded access program, which is technically a Treatment IND but functionally operates like the open study portion of a parallel track program, began in October 1989 -- several weeks before the Phase II/III studies began. Carter did not cite widespread availability of ddI nor the earlier start of the expanded access arm as the direct cause of clinical trial enrollment problems. Instead, he identified negative publicity stemming from adverse reactions seen in the expanded access program as the potential cause for the enrollment problems. Carter noted that the company was initially pleased with enrollment rates in ddI clinicals. However, Carter pointed to a New York Times article in March as a turning point in patient accruals. That article, Carter said, "stated that more patients were dying in expanded access than were dying in clinical research, ignoring the very obvious fact that patients in expanded access were clearly a much sicker population than the patients who were in the clinical research." The article, Carter said, "caused us a significant reception problem and...diminished accrual in research studies can actually be traced to have accelerated from the point of that article." Carter also noted that press reports on the expanded access program highlighted the incidence of pancreatitis with ddI, despite the fact that the adverse reaction was seen less in expanded access and Phase II studies than in the initial Phase I trials. Bristol-Myers Squibb later sent out a "Dear Doctor" letter alerting physicians involved in the expanded access program of the pancreatitis incidents ("The Pink Sheet" March 19, p. 8). Accrual in the studies, Carter concluded, "is not as good as we would ideally like it to be. How much of that is due to parallel track per se [and] how much of it is due [to press reports] is impossible to know, but I suspect that there is an impact." Carter cautioned that if the expanded access program, via clinical trial enrollment difficulties, adversely affects the approval process for ddI, other companies may be reluctant to participate in similar programs. "When we are approached by other pharmaceutical companies and asked 'Has your experience with ddI and parallel track been a successful one?' -- our answer is going to depend on our ability to have promptly registered the compound." If the expanded access protocol "is viewed as having impinged on our ability to promptly register the compound, then I think other companies are going to be very wary of following the path that we did." However, he added, "having said that, we are still happy and proud to have been involved in this program." The adverse effect of ddI's expanded access program on clinicals was also raised by Stanford University School of Medicine researcher Thomas Merigan at a recent National Institute of Allergy and Infectious Diseases meeting ("The Pink Sheet" June 25, T&G-4). Merigan said that enrollment in three ddI clinicals had dropped from a previous 40-60 per week to 11 per week in early June and that clinicals with Roche's ddC were also being affected.

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